AxoTrack I Sterile Procedure Kit 18G — Class II medical device recall Z-0215-2015
Terminated recall by Soma Access Systems LLC, reported 2014-11-26, distributed nationwide. There is a possibility the sterile packaging may fail before the expiration date specified on the package.
| Recall number | Z-0215-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Soma Access Systems LLC, Greenville, SC, United States |
| Recall initiated | 2014-03-24 |
| Classified | 2014-11-14 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2015-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, HK, IN, JP, PA, SG |
| Quantity | 3,530 units |
| Reason classes | sterility, device malfunction |
| Lot numbers | 62188-000, 62191-000, 62193-000, 62360-000, 62435-000, 62489-000, 62529-000, 62922-000, 63191-000 |
| Model numbers | 70956, 70957, 71489 |
| Expiration dates | 2014-02-28, 2014-03-31, 2014-04-30, 2014-10-31 |
Product
AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.
Reason for recall
There is a possibility the sterile packaging may fail before the expiration date specified on the package.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0215-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.